Initial Reduction in Ulcer Size As a Prognostic Indicator for Complete Wound Healing: A Systematic Review of Diabetic Foot and Venous Leg Ulcers.

Significance: Percent area reduction (PAR) is commonly reported in trials including diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). It is unclear how well PAR performs as a surrogate marker for complete wound closure. This review aimed to summarize all available evidence evaluating PAR as a predictor of complete DFU and VLU healing. Recent Advances: A review searching the CENTRAL, MEDLINE, EMBASE, and EMCARE databases was conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). Randomized-controlled trials and observational studies reporting PAR and any measure of its predictive ability were included. Outcomes included performance measures of PAR, timing of PAR, outcome measurement, and specific PAR cutoffs. Critical Issues: Meta-analysis was not possible due to high variability in wound duration at study start (2-48 weeks), PAR timing (2-8 weeks), PAR cutoff (-3% to 90%; determined post hoc in most studies), and outcome assessment (10-24 weeks). Six studies (21,430 DFU patients) report PAR as having acceptable to outstanding discriminatory ability (C-statistic 0.720-0.910). Five studies (29,775 VLU patients) report PAR as having poor to excellent discriminatory ability (C-statistic 0.680-0.830). One study (241 DFU and VLU patients) reports PAR sensitivity and specificity of 58.5% and 90.5%, respectively. All studies were determined to have high risk of bias. Future Directions: Despite promising discriminatory ability, most studies report post hoc analysis of patients in randomized trials, are highly heterogenous in study design, and have high risk of bias. There is scant evidence to support PAR in isolation as a surrogate for complete DFU or VLU healing in routine clinical practice.

Systematic review of groin wound surgical site infection incidence after arterial intervention.

The objectives were to determine the surgical site infection incidence (including superficial/deep) fter arterial intervention through non-infected groin incisions and identify variables associated with incidence. MEDLINE, EMBASE and CENTRAL databases were searched for randomised controlled trials and observational studies of adults undergoing arterial intervention through a groin incision and reported surgical site infection. Infection incidence was examined in subgroups, variables were subjected to meta-regression. One hundred seventeen studies reporting 65 138 groin incisions in 42 347 patients were included. Overall surgical site infection incidence per incision was 8.1% (1730/21 431): 6.3% (804/12 786) were superficial and 1.9% (241/12 863) were deep. Superficial infection incidence was higher in randomised controlled trials (15.8% [278/1762]) compared with observational studies (4.8% [526/11 024]); deep infection incidence was similar (1.7% (30/1762) and 1.9% (211/11 101) respectively). Aneurysmal pathology (ß = -10.229, P < .001) and retrospective observational design (ß = -1.118, P = .002) were associated with lower infection incidence. Surgical site infection being a primary outcome was associated with a higher incidence of surgical site infections (ß = 3.429, P = .017). The three-fold higher incidence of superficial surgical site infection reported in randomised controlled trials may be because of a more robust clinical review of patients. These results should be considered when benchmarking practice and could inform future trial design.

Neoadjuvant chemoradiotherapy versus immediate surgery for resectable and borderline resectable pancreatic cancer: Meta-analysis and trial sequential analysis of randomized controlled trials.

We aimed to compare resection and survival outcomes of neoadjuvant chemoradiotherapy (CRT) and immediate surgery in patients with resectable pancreatic cancer (RPC) or borderline resectable pancreatic cancer (BRPC). In compliance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement standards, a systematic review of randomized controlled trials (RCTs) was conducted. Random effects modeling was applied to calculate pooled outcome data. Likelihood of type 1 or 2 errors in the meta-analysis model was assessed by trial sequential analysis. A total of 400 patients from four RCTs were included. When RPC and BRPC were analyzed together, neoadjuvant CRT resulted in a higher R0 resection rate (risk ratio [RR]: 1.55, p = 0.004), longer overall survival (mean difference [MD]: 3.75 years, p = 0.009) but lower overall resection rate (RR: 0.83, p = 0.008) compared with immediate surgery. When RPC and BRPC were analyzed separately, neoadjuvant CRT improved R0 resection rate (RR: 3.72, p = 0.004) and overall survival (MD: 6.64, p = 0.004) of patients with BRPC. However, it did not improve R0 resection rate (RR: 1.18, p = 0.13) or overall survival (MD: 0.94, p = 0.57) of patients with RPC. Neoadjuvant CRT might be beneficial for patients with BRPC, but not for patients with RPC. Nevertheless, the best available evidence does not include contemporary chemotherapy regimens. Patients with RPC and those with BRPC should not be combined in the same cohort in future studies.